1.1 本指南将生命周期方法应用于清洁工艺验证，包括清洁工艺的开发、鉴定和验证。适用于药品（包括活性药物成分（API））；所有剂型；非处方药和中性药物产品、兽医产品、生物制品、临床用品、先进治疗药物产品（ATPM）、医疗器械制造；也适用于其他健康、化妆品和消费品。 1.2 本指南仅侧重于设备产品接触表面和医疗器械表面的清洁，不包括消毒、灭菌或非产品接触表面（其他现有指南中包括:参考 ( 1. ) , 2. USP<1072>，指南 第2614页 、ISO 14698和ISO 14937）。 1.3 以国际单位制表示的值应视为标准值。本标准不包括其他测量单位。 1.4 本标准并不旨在解决与其使用相关的所有安全问题（如有）。本标准的使用者有责任在使用前建立适当的安全、健康和环境实践，并确定监管限制的适用性。 1.5 本国际标准是根据世界贸易组织技术性贸易壁垒（TBT）委员会发布的《国际标准、指南和建议制定原则决定》中确立的国际公认标准化原则制定的。 =====意义和用途====== 4.1 本指南中所述方法的应用适用ICH Q9中介绍的基于风险的概念和原则。如ICH Q9中所述，清洁的工作水平、形式和文件也应与风险水平相适应。 4.2 本指南中所述方法的应用应用了FDA中引入的许多基于科学、基于风险和统计的概念和原则 工业过程验证指南:一般原则和实践 ( 3. ) 国内药品制造商成品剂型试点计划的质量管理成熟度；计划公告。 4.3 本指南支持并符合ICH Q8、ICH Q9、ICH Q10、ICH Q1 1和ICH Q12中的元素。 4.4 本指南支持并符合ISO 14971的内容和意图。 4.5 关键概念- 本指南应用了以下关键概念:( 1. )质量风险管理( 2. )基于科学的方法( 3. )基于统计的方法( 4. )过程理解( 5. )持续改进，以及( 6. )ICH Q系列中描述的生命周期管理。

1.1 This guide applies the life-cycle approach to cleaning process validation, which includes the development, qualification, and verification of cleaning processes. It is applicable to pharmaceuticals (including active pharmaceutical ingredients (APIs)); all dosage forms; over-the-counter medicinal and neutraceutical products, veterinary products, biologics, clinical supplies, advanced therapy medicinal products (ATPM), medical device manufacturing; and is also applicable to other health, cosmetics, and consumer products. 1.2 This guide is focused only on the cleaning of equipment product contact surfaces and medical device surfaces and does not cover disinfection, sterilization, or non-product contact surfaces (which are covered under other existing guides: Ref ( 1 ) , 2 USP <1072>, Guide E2614 , ISO 14698, and ISO 14937). 1.3 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.4 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.5 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. ====== Significance And Use ====== 4.1 Application of the approach described within this guide applies risk-based concepts and principles introduced in ICH Q9. As stated in ICH Q9, the level of effort, formality, and documentation for cleaning should also be commensurate with the level of risk. 4.2 Application of the approach described within this guide applies many of the science-based, risk-based, and statistical concepts and principles introduced in the FDA’s Guidance for Industry Process Validation: General Principles and Practices ( 3 ) and Quality Management Maturity for Finished Dosage Forms Pilot Program for Domestic Drug Product Manufacturers; Program Announcement. 4.3 This guide supports, and is consistent with, elements from ICH Q8, ICH Q9, ICH Q10, ICH Q11, and ICH Q12. 4.4 This guide supports and is consistent with the content and intent of ISO 14971. 4.5 Key Concepts— This guide applies the following key concepts: ( 1 ) quality risk management, ( 2 ) science-based approach, ( 3 ) statistics-based approach, ( 4 ) process understanding, ( 5 ) continued improvement, and ( 6 ) life-cycle management as described in the ICH Q series.